Catalent has launched its new Case Management Service, which has been specifically designed to address the unique challenges associated with the safe and timely delivery of advanced therapies to patients by providing professional supply chain oversight from program start to finish.

The supply chain logistics for advanced therapy medicinal products (ATMPs), such as cell and gene therapies, is complex because of their inherent sensitivity, high value, and certain patient-specific complexities of delivering each dose. Ensuring these products are efficiently managed and correctly transported reduces the risk of potential disruption to the manufacturing schedule and, ultimately, the administration of the therapy to the patient.

Customers adopting the service will be assigned a Case Manager, who will act as a single point of contact for their project, from beginning to end, regardless of whether the therapy is being manufactured by Catalent or elsewhere. The Case Manager will coordinate the scheduling of material collection, the manufacturing slot for the therapy, arrange shipments and continuously manage its status. They will also ensure that proper documentation and traceability, including chain of custody and of identity, are maintained throughout the product lifecycle, providing around-the-clock support and issue resolution.

“This service combines Catalent’s deep expertise, extensive capabilities, and leadership in cell and gene therapy manufacturing with our robust packaging and clinical supply services to fill a critical need in the successful delivery of these therapies to patients,” said Delara Motlagh, vice president, global cell therapy for Catalent. “The Case Management Service enables customers, who are often resource-constrained, to focus their resources on the science and development of advanced therapies, and allow highly experienced specialists to manage the complex and highly time-critical supply chain for cell and gene therapies.”

Trish Demko, director, case management services at Catalent, said, “Customers have repeatedly informed us that they are looking for a streamlined supply chain that optimizes efficiency and also meets the very specific needs of their projects, so we designed this case management program to provide the flexibility and scalability to meet both the immediate and future needs of their studies. Combined, our case management team has more than three decades of experience of managing the critical logistics for advanced therapies, including assuring the chain of identity and chain of custody, as well as the complex and time sensitive communication needs that these programs present.”

Customers that choose Catalent to manufacture their therapies will gain access to a robust cell and gene therapy development and manufacturing network, including gene therapy manufacturing facilities in Baltimore and Harmans, Maryland, an induced pluripotent stem cell (iPSC) development and differentiation facility in Dϋsseldorf, Germany, and clinical and commercial cell therapy manufacturing facilities in both Princeton, New Jersey and Gosselies, Belgium, which recently opened one of the world’s largest commercial-scale cell therapy manufacturing facilities.